Medical Liability: Current Status and Patient Safety

Accusations of negligence and the harm they do can be greatly reduced by a no-fault compensation, more realistic expectations, and an appropriate continuing education system for health professionals. The usual reaction to the term "medical negligence" is: A healthcare professional has done something wrong and I want monetary compensation for it". In practice, however, a careful interpretation is needed. Nowadays "negligence" does not turn out to be such a simple concept. It is sometimes considered to be a synonym for malpractice but in fact it has to be confined to two specific meanings: the use of outdated knowledge and skills (negligence with regard to continuing education); and not taking the safety measures that are known to be necessary (negligence with regard to standard procedures). Both definitions are complex and relative, because the rapid evolution of the health professions. Most examples of alleged negligence in the health services do not concern recent scientific developments but simple treatments and safety procedures that are long-standing common knowledge in the health sector. Public attitudes towards the health services and health professionals used to be submissive on the whole, but fortunately they have changed dramatically during the last few decades. People have become much more aware of the real danger of negligence, and indeed it sometimes seems as if the pendulum has swung from one extreme to other: from blind trust in the almost divine skills of health professionals to the feeling that if treatment or advice do not yield the desired results someone must have made a mistake, should take blame and people should be monetarily compensated. Medical negligence exists almost in all the countries, but in most of the countries it is on such a small scale that at present there is no impact on the cost, quality and availability of healthcare. In USA it has reached at the dangerous levels. The first obvious need is to narrow the gap between public expectations and the reality of what the health system can deliver. Unfortunately, the parties on both sides of the gap are resistant to change in this direction. The public feel that their financial contribution to the health sector -- whether through taxation, insurance or fees for service -- entitles them to high expectations, just as they would demand value for money when they buy other services or consumer goods. In some health systems an effort is made to bridge gap, but this takes the form of a legalistic contractual presentation of every foreseeable unhappy event. Communication skills, public information, and health education can greatly help to narrow the gap, and they need more emphasis in most of today's health systems. The second thing to do is to find better ways of maintaining and updating health professionals' knowledge and skills. The most promising solution is to develop a system which will combine a compulsory minimum of further training with plenty of opportunities for the highly motivated to learn more on a voluntary basis.

The purpose of this document is to develop patient safety curriculum and to discuss tasks ahead of health care providers and organizations, and require all those involved in care to understand the extent of harm to patients and why health care must move to adopt a safety culture. Patient safety education and training is only the beginning to occur at all levels. Medical students, as future doctors and healthcare leaders, must also be prepared to practice safe health care. Though medical curricula are continually changing to accommodate the latest discoveries and new knowledge, patient safety knowledge is different from other because it applies to all areas of practice. In recent years, a science of patient safety has developed. Harm to patients is not always inevitable and can be avoided. To achieve this, clinicians and institutions must learn from past errors, and learn how to prevent future errors. We need to adapt our ways of working to make safe health care a robust and achievable goal. Traditionally, curricula for doctors and medical students have focused on pure clinical skills: diagnosis of illness, treatment of disease, after-care and follow-up. However, team working, quality improvement and risk management have been overlooked. These skills are fundamental to patient safety. It is therefore fitting that the Women's Health and Education Center (WHEC) with its partners in health, has developed this curriculum which will enable and encourage medical schools and healthcare providers to include patient safety in their courses. Reducing harm caused by health care is a global priority. Incorporating the knowledge of how to do this into the medical student curriculum is an urgent necessity. This Curriculum Guide is only a start. A plan is underway to adapt it for use by other healthcare professionals including nurses and pharmacists. It is only one strand of what we need to build safer healthcare systems. However, there is no doubt that engaging clinicians from the earliest stages of their training is crucial.

Background

The cost of medical malpractice in the United States is $55.6 billion a year, which is 2.4 percent of annual healthcare spending in 2010 (1). The researchers in this study estimate including $45.6 billion in what is known as defensive medicine costs -- when doctors prescribe unnecessary tests or treatments to avoid lawsuits. The actual cost of medical liability in the United States has been unclear. The authors of this study say their analysis is the most comprehensive, and reliable estimate to date. Physicians are the primary target of malpractice. According to records of malpractice payments in 2006, 79% of payments were made in claims against physicians; dentists accounted for 10.3% and all other healthcare practitioners constituted 10.7% (2). Lower quality of care does not appear to be the cause of most malpractice claims, as no significant differences have been found in quality between physicians who have and have not been sued. The risk of malpractice varies among medical specialties and typically increases with the frequency with which procedures are performed and with greater potential for catastrophic injury. A 2005 study concluded that obstetrician-gynecologists in USA experience a professional liability claim every 11 years of practice and a trial every 69 years. The more recent 2009 Survey on Professional Liability conducted by the American College of Obstetricians and Gynecologists (ACOG) found that 90.5% of respondents experience at least one professional liability claim, with an average of 2.69 claims per obstetrician and gynecologist (3). This survey found that 62.1% of claims involved obstetric care, while 37.9% concerned gynecologic care. According to the 2000 landmark Institute of Medicine report, To Err is Human: Building a Safer Health System, 44,000 to 98,000 deaths are caused by medical errors in U.S. hospitals each year, with more than 7,000 of those deaths attributable to medication error (4). The primary goals of the U.S. medical malpractice system are to compensate individuals who have been harmed through medical negligence, to hold a responsible individual accountable, and to provide deterrence to unsafe medical practices or medial errors. Most patients who sustain a medical injury as a result of medical negligence do not sue and a substantial number of claims do not involve negligence, which leaves the primary goals of the malpractice system unmet. Calls for reform of the malpractice system have been made in light of these findings.

In the United Kingdom physicians have been on the receiving end of litigation for more than 100 years. Most of these litigation concerned allegations of "charlatanism and quackery" and breach of contract, and its growth was such that, in 1885 the first medical-defense organization, the Medical Defense Union, was established. It was followed by the Medical Protection Society in 1892 and the Medical Defense Union of Scotland in 1902. In United Kingdom the cost of litigation to the National Health Services (NHS) rose inexorably. By 1995 the National Health Service Litigation Authority was established. Its aims and objectives were "to administer schemes under which NHS bodies could pool their clinical negligence liabilities and to promote high standards of risk management in the NHS". In 2008-2009, 6080 claims of clinical negligence against NHS bodies were received by the Authority, up from 5,470 claims of clinical negligence and 3,380 claims of nonclinical negligence in 2007-2008. A total of £769 million was paid in connection with clinical negligence claims during 2008-2009, up from £633 million in 2007-2008 (5). Awards in the United States are much higher, the reason being that damages in USA are punitive, whereas those in the United Kingdom these are compensatory.

Medical injury administrative compensation systems are well-established in many countries, including Sweden, Norway, Australia, Canada and New Zealand. Sweden defines a compensable event in terms of avoidable injury, one which an experienced physician (general practitioner or specialist) could have avoided. In a procedure-related injury, a determination is made whether the procedure was performed properly and whether some other procedure could have satisfied the medical requirements in a less risky manner. In Denmark, the compensable event includes all avoidable, and some avoidable injuries. In both countries, fault or negligence is no longer a condition for receiving compensation (damages). It is important to note that these programs are not pure absolute liability or no-fault programs. They relate to only those injuries caused by examination, treatment or care. These systems are without blame, but they are not guarantee schemes. The patient injury compensation panel determines whether the injury or adverse outcome is within the provisions of the respective program and therefore of a compensable event. In both Denmark and Sweden more patients are compensated, the ground for compensation is more objective, rules of evidence are more liberal, and there is no economic risk to the patient. Time for handling claims is shorter and administrative costs are low. Perhaps the most important difference is; there are better relations between patients and physicians. Physicians can help patients without risk of sanctions. Patients are unlikely to file grievances with the complaints system if helped by their physicians to receive compensation. Physicians can concentrate on what they do best. As the birth injury legislation and the Danish and Swedish systems demonstrate, it is possible to select those adverse medical outcomes that deserve compensation. The authors of this study believe that demonstration projects will convince patients, physicians, actuaries, insurers, and policy-makers that compensation of patient injury can be fairly and promptly made on a sound financial basis through administrative compensation mechanisms (6). There would be no need for recourse to the tort system to determine whether or not an event is compensable (6).

Key Concepts in Malpractice

Medical malpractice is processed in civil court system or according to tort law in USA, most of the time. Overall, the civil court system provides a mechanism for an individual or group to recover damages when a tort (derived from the French word for "wrong") is committed against a person or property. Torts are classified as either intentional or negligent. Several intentional torts may be committed by physicians, including assault and battery (e.g. operating on a patient without informed consent), false imprisonment (e.g. forcing a patient to stay in the office until a bill is paid), and fraud (e.g. claiming cure when the physician knows cure is not possible). A negligent tort involves the omission or commission of an act that a reasonably prudent person would or would not do under given circumstances. The statutes of limitations for medical malpractice vary according to the state, with many states having statutes that vary by cause of action and special rules for minors. In general, a medical claim must be filed within 1 to 5 years after the malpractice occurred or after the alleged injury was discovered if it was not immediately evident.

Standard of care and medical negligence

In a medical malpractice case, the plaintiff has the burden of establishing the appropriate standard of care and demonstrating that the standard of care has been breached. The standard of care is primarily defined by other practitioners with similar qualifications, who provide expert testimony about how they would have managed an individual's care under the same or similar circumstances (7). In general, expert testimony is based on the physician expert's knowledge, skill, experience, and training and may be supplemented by published literature, practice guidelines, and surveys of practitioners. The focus is whether the physician's actions met or breached the standard of care and, if the latter, whether the plaintiff was harmed as a result of the breach (8). There are several examples of health care systems that have attempted to establish standardized guidelines for obstetric care with varying success. The major advantage of system-based guidelines is that one can, in theory, more readily standardize an approach to clinical care for practitioners and support staff in a single system or hospital. In most major health care systems and academic institutions in the United States, there is a movement towards establishing standardized clinical guidelines in an effort to improve patient safety and clinical outcomes. There are many different categories that foster standardization including clinical guidelines, algorithms of care, templates for electronic medical records, surgical check-lists, and other protocols designed to improve patient care. The successful implementation of these approaches has been shown to require more than just educational efforts for the health care team members.

According to tort law, four elements must be established for a ruling of malpractice (9):

Duty: The physician owed a duty to meet a particular standard of care.

Breach of duty: The physician failed to perform the owed duty.

Causation: There is a causal connection between the physician's failure and the patient's injury.

Damages: An injury occurred for which monetary compensation is adequate relief. Damages sustained by the patient care are compensatory and/or punitive. Compensatory damages consist of compensation for direct costs, such as for lost earnings and medical expenses (current and future), as well as compensation for indirect costs, such as pain, emotional distress, and loss of consortium. Punitive damages are awarded to plaintiff when the physician's actions are found to be intentionally harmful or grossly negligent.

These elements must be shown by a "preponderance of the evidence", defined as more than 50% probability, a lower standard than the "beyond a reasonable doubt" used in criminal law (8). Malpractice cases in U.S. are decided on the basis of what a "jury is likely to think is fact" rather than actual fact.

Informed Consent

The informed consent law in medicine was originally developed from battery, an intentional tort (9). The primary goal of informed consent is to protect patients by requiring that physicians provide a balanced discussion of a proposed procedure/treatment as well as of the alternative options, so patients can make informed medical decisions. Informed consent was once required only for invasive procedures but the scope of procedures has expanded to include complex treatments (e.g. radiation therapy, chemotherapy), and a separate written consent is required for the use of anesthesia (general, spinal/epidural, or regional) in some states (10). Informed consent is an ethical concept that has become integral to contemporary medical ethics and medical practice. As an ethical doctrine, informed consent is a process of communication whereby a patient is enabled to make an informed and voluntary decision about accepting or declining medical care. In recognition of the ethical importance of informed consent, the Committee on Ethics of the ACOG affirms the following eight statements (11):

Obtaining informed consent for medical treatment, for participation in medical research, and for participation in teaching exercises involving students and residents is an ethical requirement that is partially reflected in legal doctrines and requirements.

Seeking informed consent expresses respect for the patient as a person; it particularly respects a patient's moral right to bodily integrity, to self-determination regarding sexuality and reproductive capacities, and to support of the patient's freedom to make decisions within caring relationships.

Informed consent not only ensures the protection of the patient against unwanted medical treatment, but it also makes possible the patient's active involvement in her medical planning and care.

Communication is necessary if informed consent to be realized, and physicians can and should help to find ways to facilitate communication not only in individual relations with patients but also in the structured context of medical care institutions.

Informed consent should be looked on as a process rather than a signature on a form. This process includes a mutual sharing of information over time between the clinician and the patient to facilitate the patient's autonomy in the process of making ongoing choices.

The ethical requirement to seek informed consent need not conflict with physicians' overall ethical obligation of beneficence; that is, physicians should make every effort to incorporate a commitment to informed consent within a commitment to provide medical benefit to patients and thus to respect them as whole and embodied persons.

When informed consent by the patient is impossible, a surrogate decision maker should be identified to represent the patient's wishes or best interests. In emergency situations, medical professionals may have to act according to their perceptions of the best interests of the patient; in rare instances, they may have to forgo obtaining consent because of some other overriding ethical obligation, such as protecting the public health.

Because ethical requirements and legal requirements cannot be equated, physicians also should acquaint themselves with federal and state legal requirements for informed consent. Physicians also should be aware of the policies within their own practices because these may vary from institution to institution.

The Centers for Medicare and Medicaid Services (CMS) mandates that all medical records (inpatient and outpatient) contain completed written informed consent forms for all procedures and treatments (10). In 2007 CMS also issued new interpretive guidelines for informed-consent documentation in patients' medical records. According to these guidelines, informed consent is defined as, "the patient or patient's representative is given (in a language or means of communication he/she understands) the information, explanations, consequences, and options needed in order to consent to a procedure or treatment" (10).

The limits of informed consent: Because informed consent admits to degrees of implementation, there are limits to its achievement. These are not only the limits of fallible knowledge or imperfect communication. They are limitations in the capacity of patients for comprehension and for choice. Assessment of patient capacity is in itself a complex matter, subject to mistakes and bias. Hence, a great deal of attention has been given to criteria for determining individual capacity (and the legally defined characteristic of "competence") and for just procedures for its evaluation (11,12). When individuals are entirely incapacitated for informed consent, the principles of respect for the persons and beneficence require that the patient be protected.

Malpractice-Related Laws

Several laws have been established to provide healthcare professionals specific types of protection against legal liability. These laws, which include Good Samaritan laws, charitable immunity laws, and apology statutes, vary by state. The American Medical Association (AMA) has developed a resource that describes the details of each state's law (13).

Good Samaritan Laws: These were developed to protect individuals who voluntarily render emergency aid to an injured person. A "volunteer" can help an injured person on the grounds of implied consent, but if person is conscious and can respond, first asking permission to help him or her is recommended (13). In most states, a person is not legally obligated to provide first aid (unless it is part of a job description), but when aid is provided, the person giving aid has a duty to be reasonably careful (13). Good Samaritan laws protect a volunteer against legal liability in the event he or she makes an error during the provision of emergency care. Usually, two conditions must be met: the aid must be given at the scene of the emergency and the volunteer cannot have another motive, such as the desire to be paid (13).

Charitable Immunity Laws: These are designed to protect physicians and other healthcare professionals who volunteer their services in free healthcare to uninsured individuals. These laws also differ from state to state, but they act to either raise the negligence standard of care (from simple negligence to gross negligence) or indemnify volunteer healthcare professionals with liability protection as if they were government employees (14). Some state laws have elements of both approaches. Requiring evidence of gross negligence (defined as "willful", "wanton", or "reckless" negligence) makes it more difficult to prove medical negligence. States that indemnify volunteer healthcare professionals as government employees have a legal defense fund to cover defense costs and monetary damages; in some cases, there is an established limit on the total amount of compensation that can be paid (15). Thus, such indemnification, also known as the State Tort Claims Act, can help to limit loss. Charitable immunity legislation has been established in all states (all the District of Columbia) except for Alaska, California, Massachusetts, Nebraska, New Mexico, New York, and Vermont. Retired physicians are specifically referenced in the legislation in 12 states, with 3 states (Pennsylvania, Washington, and West Virginia) having legislation only for retired physicians (14). In addition to state statutes, federal legislation also protects healthcare professionals who provide free health care. The Volunteer Protection Act of 1997 provides protection against liability for a volunteer clinician "acting within his or her scope of duties in a non-profit organization" (14). This law also limits punitive damages to cases in which there is clear and convincing evidence of willful or criminal misconduct or conscious, flagrant indifference to the rights or safety of the individual harmed. Although state and federal charitable immunity laws do not guarantee that a malpractice claim will not be filed, the laws appear to have limited the number of malpractice claims, as physicians in volunteer settings are rarely targets of malpractice claims.

Apology Statutes: These are designed to promote disclosure of medical errors by protecting physicians who apologized for an error. According to these laws, expressions of apology made after a medical error are excluded from evidence in a malpractice suit. There are two types of apology statutes (16):

Admission of fault: protects a physician's admission of fault and error (in addition to expressions of sympathy, regret, and condolence)

Most states have adopted the sympathy only law (16). Massachusetts was the first state to enact an apology law, in 1986; since then 34 additional states and the District of Columbia have enacted one of these two types of apology statutes. Because most apology laws have been enacted since 2005, time to evaluate their impact on malpractice litigation has been limited.

Most Common Allegations in Obstetrics and Gynecology

Predictably, the most common reason for suit in obstetrics and gynecology is that a medical error injured a patient. Thus, the prevailing principle in reducing litigation risk is to practice good medicine. An analysis of 189 closed perinatal claims from 2000 to 2005 concluded that 70% of claims involving obstetric practice were the result of substandard care (17). Despite best practices, physicians may be subject to suit.

Mismanagement of Labor and Delivery: Most suits alleging mismanagement of labor involve allegations of inappropriate use of oxytocin. The U.S. Food and Drug Administration approved oxytocin for the medical induction and stimulation of labor. It did not approve oxytocin for elective induction or stimulation of labor. Although permissible, "off-label" use increases the risk of litigation and warrants appropriate documentation in the medical record. One study determined that following published, checklist-driven protocols for administration of oxytocin, misoprostol, and magnesium sulfate might prevent 45% of cases involving fetal monitoring in non-vaginal birth after cesarean delivery (VBAC) cases and 16% of maternal injury cases (17,18). Hospitals should establish policies and procedures regarding the use of oxytocin for labor induction and augmentation. Oxytocin dose-related side effects include uterine tachysystole and Category II and III fetal heart rating tracings. Careful assessment for appropriate progress in labor is necessary, particularly to avoid claims of the inappropriate delay when cesarean delivery is required. When resuscitative measures are required, one should document the observed changes and the response to treatment.

Neurologically Impaired Newborns: Peripartum hypoxic ischemic encephalopathy is the most frequent claim in medical liability cases involving birth injury. Of note, 70% of neonatal encephalopathy is attributable to antepartum events (19). However, 19% of newborns still meet criteria for intrapartum hypoxia, with 10% having a sentinel event that may be associated with intrapartum hypoxia (19). A study involving non-VBAC cesarean delivery with fetal heart rate abnormalities determined that an available in-house obstetrician could have prevented 23% of cases (14% of total liability cases) (20). Delayed physician evaluation and delayed delivery were the primary issues leading to an adverse outcome and litigation in every case (17). Claims regarding intrapartum hypoxia commonly cite an unreasonable delay in proceeding to delivery, particularly cesarean delivery, or a difficult operative vaginal delivery. When a sudden and unpredictable fetal heart rate abnormality occurs, the case usually focuses on the alleged delayed response of the obstetric team in the emergency situation. Most commonly cited is non-adherence to the "30-minute rule". As published in the Guidelines for perinatal care, "All hospitals offering labor and delivery services should be equipped to perform emergency cesarean delivery .... The consensus has been that hospitals should have the capability of beginning a cesarean delivery within 30 minutes of the decision to operate." (19)

Vaginal Birth After Cesarean Delivery (VBAC): VBAC grew in popularity in the 1980s and 1990s. The risk of uterine rupture after a prior low transverse uterine incision is 0.5-1.0% (21). Studies demonstrate a positive association between malpractice premiums and cesarean delivery rates; estimates are that a $ 10,000 decrease in premiums would lead to a 1.45% increase in the VBAC rate and a 0.7% to 1.18% decrease in cesarean delivery status (22). The recognized risks and some adverse outcomes have prompted some states (i.e., Florida) and hospital systems to impose practice guidelines for VBAC. Presently ACOG recommends "immediate availability" of physicians providing VBAC management. Uterine rupture, with its potentially devastating consequences, occurs in 800 per 100,000 attempted VBAC patients with spontaneous labor. The risk of intrapartum fetal death is 20 per 100,000 women who attempted a trial of labor (21). Perinatal death occurs in 6% of uterine ruptures (21). Although no maternal deaths have been reported in this study, 14-33% of women require hysterectomy after uterine rupture (21). Clear documentation of informed-consent discussions in early labor, timely documentation of labor progress and fetal status, and close vigilance throughout labor are critical for safe conduct of a VBAC and defensibility in the event of litigation. Patients with classical uterine scars should not undergo attempted VBAC. Patients with a previous low-vertical uterine incision or an unknown uterine scar have been found to have similar VBAC success rates as those with low-transverse uterine incisions. However, labor augmentation should be avoided with an unknown scar, as there is a demonstrable increase in uterine rupture with augmentation. Also, patients with two or more prior cesarean section deliveries have a higher rate of uterine rupture than with one prior cesarean delivery (1,590 per 100,000 compared with 560 per 100,000) (22).

Shoulder Dystocia: The resultant brachial plexus injury accounts for almost 11% of lawsuits in obstetrics (23). Traditional thinking was that brachial plexus injury resulted from excessive traction at the time of delivery and its presence was proof of medical negligence. However, evidence indicates that some brachial plexus injuries occur during uncomplicated deliveries or even in utero (20,24). Recognized risk factors include a prior pregnancy complicated by shoulder dystocia with resultant Erb's palsy, prior large newborns, gestational diabetes, macrosomia, and a midpelvic operative delivery in fetuses with an estimated weight greater than 4,000 g (24). The incidence of shoulder dystocia is twice as frequent with operative delivery in both diabetic (23.8% compared with 12.0%) and non-diabetic (13.3% compared with 6.5%) patients (25). Thus, physicians should approach an operative vaginal delivery, particularly in combination with dysfunctional labor, with caution. Documentation should include the indications for operative intervention, fetal status, fetal position, and clinical pelvic adequacy, and the estimated fetal weight. Delivery documents should include the number of pulls or pop-offs with vacuum application, the immediate neonatal status, and any signs of fetal trauma. A dictated or standard operative note is recommended, including all pertinent information such as neonate birth weight, Apgar scores, cord gases, neonatal resuscitation, maternal anesthesia, and estimated blood loss. Studies demonstrate that no permanent central nervous system sequelae occur before a head-to-body interval of 8 minutes (26). 54% of shoulder dystocia cases payment has been a result of poor documentation that was either incomplete or inconsistent (20). This paper also determined that better care and documentation might have avoided payment in 77% of shoulder dystocia cases.

Delayed Diagnosis of Breast Cancer: One study regarding the outcome of such malpractice suits determined that patients discovered the breast lesion more frequently than the physician (86% compared with 9% of cases) (27). A palpable mass, even with a negative mammogram, warrants further evaluation with ultrasonography, magnetic resonance imaging, or biopsy. Litigation cases that are usually lost involve patients older than 40 years, a tumor size 2 cm or greater, or the failure to biopsy a palpable or suspicious lesion. Best practices that follow the ACOG's recommendations include screening mammography for women in their 40s every 1-2 years and annual mammography in women aged 50 or older (28). Individualized risk assessment is available with the National Cancer Institute's Breast Cancer Risk Assessment Tool, available at http://www.cancer.gov/bcrisktool. This online interactive tool estimates a woman's lifetime risk of developing invasive breast cancer by imputing her age, personal and family history, her reproductive history, and her race. Careful documentation of physical findings, diagnostic studies, and patient counseling are critical to optimal patient care and enhanced defensibility in the event of suit.

Pregnancy of Unknown Location: A rapidly increasing source of medical liability actions relates to the unintended treatment of an intrauterine pregnancy with methotrexate, misdiagnosed as an ectopic pregnancy (29). Case reviews show several recurrent patterns: errors in interpreting the ultrasound studies, improper correlation of human chorionic gonadotropin (hCG) levels and ultrasound findings, or treatment based on a single hCG level without a definitive ultrasound diagnosis of ectopic pregnancy. These tend to be errors in perception or interpretation. 80% of such cases are lost if they go to jury verdict, prompting pretrial settlement in many cases (30). Treating physicians should correlate ultrasound findings with a patient's last menstrual period, the associated hCG levels, and reproductive history, particularly assisted reproduction. Transvaginal ultrasonography usually shows a yolk sac at 4 to 5 weeks for the last menstrual cycle. We suggest, if on the initial evaluation, the pregnancy location is unknown and the patient is stable, avoid methotrexate treatment. Careful follow-up with serial hCG levels, repeat ultrasonography is indicated, and repeat examination will clarify the location and viability of a pregnancy. Methotrexate should only be used in clinically stable patients when ultrasonography confirms an extrauterine location or the pregnancy location remains unknown with abnormally rising serial hCG levels.

Patient Safety Objectives

The Women's Health and Education Center (WHEC) continues to emphasize its long-standing commitment to quality and patient safety by codifying a set of objectives that should be adopted by healthcare providers in their practices. Healthcare providers should incorporate elements of patient safety into their practices and also encourage others to use these practices. The quest for patient safety is an ongoing, continuously refined process incorporating information sharing and collaboration into daily practice. Emphasizing compassion, communication, and patient-focused care will aid in creating a culture of excellence. Opportunities to improve patient safety should be used whenever identified. We encourage these principles in the hospitals and other settings where they practice:

Make safety a priority in every aspect of practice;

Improve communication;

Identify and resolve problems;

Reduce the likelihood of surgical errors;

Implement recommended safe medication practices;

Develop a commitment to encourage a culture of patient safety;

Establish a partnership with patients to improve safety;

Improve legibility of handwriting;

Check for drug allergies and sensitivities;

Avoid use of non-standard abbreviations.

Generally, most medical errors should be handled in a non-punitive environment to improve reporting and to gain an understanding of the breadth of problems in healthcare systems. According to Agency for Healthcare Research and Quality (31) the "involvement of patients in decisions about their own medical care is good for their health -- not only because it is a protection against treatment that patients might consider harmful, but because it contributes positively to their well-being". Patients should be encouraged to ask questions about medical procedures, the medications they are taking, and any other aspect of their care. Medication use errors are the largest single source of preventable adverse events. To minimize the risk of medication use errors, healthcare providers should focus on several elements of medication order writing, such as the appropriate use of decimals and zeros, standard abbreviations, and assuring legibility (32). Additionally, it is important to assist the patient in understanding the medical condition for which a medication is prescribed. Focusing on elements that may prevent prescription errors and helping patients understand how to use prescribed medication properly may help lower the occurrence of medication use errors.

"Do Not Use" Abbreviations

There are numerous abbreviations used in health care that have several different meanings. Some of these abbreviations may be mistaken for other abbreviations, numbers, or symbols, and these mistakes can have serious consequences. In 2004, as part of its National Patient Safety Goals, the Joint Commission on Accreditation of Healthcare Organizations (Joint Commission) added a list of "do not use" abbreviation as part of Goal 2B, "Standardize a list of abbreviations, acronyms and symbols that are not to be used throughout the organization".

* Applies to all orders and all medication-related documentation that is handwritten (including free-text computer entry) or on preprinted forms.

† A "trailing zero" may be used only where required to demonstrate the level of precision of the value being reported, such as laboratory results, imaging studies that report size of lesions, or catheter/ tube sizes. It may not be used in medication orders or other medication-related documentation.

Summary

Medicine has changed greatly over the last century. Our knowledge of the physiology, biochemistry and genetics of human life has improved, as has our understanding of the diseases that affect health. As the technical ability to treat disease has grown, the complexity of medical practice has increased significantly. The same drugs and surgeries that can save lives have the potential to cause harm. Modern health care is delivered in teams, not by individuals. Modern clinicians rely on the support of intricate healthcare systems to enable them to carry out their task. Errors can occur at each stage in any of these processes. There is a constant threat of accidental harm, which cannot easily be removed. The risk management and related issues emphasize the need for primary care clinicians to establish risk management strategies in their practice. A definition of tort (personal-injury) law and several legal issues related to malpractice lay the foundation for a better understanding of such key concepts as medical negligence and the standard of care, adequate informed consent, statutes of limitations, and measure of damages. In addition, the malpractice-related laws such as apology statutes, Good Samaritan laws, and charitable immunity laws; knowledge of these laws can help healthcare professionals better protect themselves from malpractice. Descriptions of the common characteristics of malpractice claims and the consequences of malpractice can enhance healthcare professionals' understanding of the underlying causes and motivations of malpractice claims and to improve their ability to handle a malpractice lawsuit. Tort reform may address the proposed solutions to malpractice problems and participate in this national debate. The course closes with a brief discussion of the initial steps involved in responding to a malpractice claim and minimizing loss. Because of the potential for ambiguity that might result in a medication error and subsequent patient harm, using fewer or perhaps no abbreviations is suggested.

Funding: The Women's Health and Education Center (WHEC) with its partners in health, has developed this curriculum which will enable and encourage medical schools and healthcare providers to include patient safety in their courses. The series on Medical Liability is funded by WHEC Initiative for Global Health.

American College of Obstetricians and Gynecologists, American Academy of Pediatrics, eds. Neonatal encephalopathy and cerebral palsy. Defining the pathogenesis and pathophysiology. Washington DC: ACOG 2008

Shwayder JM. Waiting for the tide to change -- reducing risk in the turbulent sea of liability. Obstet Gynecol 2010;116:8-15